BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 2780929 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13271
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 13, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED HIGH OUT OF RANGE SHOCK IMPEDANCES OF GREATER THAN 125 OHMS IN TRIAD CONFIGURATION. IT WAS NOTED THAT THERE WAS NOISE OBSERVED ON THE SHOCK CHANNEL WITH POCKET MANIPULATION AND ISOMETRICS THAT HAS BEEN INCREASING SINCE THE IMPLANT OF THIS DEVICE. NOISE WAS ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. A REVISION PROCEDURE WAS THEREFORE PERFORMED. DURING THE PROCEDURE, AFTER DISCONNECTING AND RECONNECTING THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, THE SHOCK IMPEDANCE IN TRIAD WAS 52 OHMS INITIALLY, THEN 86 TO 88 OHMS, AND 83 OHMS ON A SUCCESSIVE SERIES OF TESTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED PERFORMING A 1.1 JOULE AND MAXIMUM ENERGY COMMANDED SHOCKS; HOWEVER, THE PHYSICIAN ELECTED TO REPLACE THIS DEVICE AS WELL AS THE PATIENT'S LEADS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R E163| 4087| T165| 0184